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<form>

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<h1>Faculty of Medicine, University of Colombo</h1>
<hr></hr>
<p>For official use</p>
<table border="1">
<tr>

<td>Application No :</td>

<td><input type="text" name="appno"></input></td>

<td>Date received :</td>
<td><input type="text" name="rdate"></input></td>
<td>/</td>
<td><input type="text" name="rmonth"></input></td>
<td>/</td>
<td><input type="text" name="ryear"></input></td>
</tr>


<tr>
<td>Reviewed by :</td>

<td><input type="text" name="reviewer"></input></td>

<td>ERC meeting date :</td>
<td><input type="text" name="mdate"></input></td>
<td>/</td>
<td><input type="text" name="mmonth"></input></td>
<td>/</td>
<td><input type="text" name="myear"></input></td>
</tr>

</table>

<h2>1. Title of project</h2>

<table border="1"><tr><td><input type="text" name="title4"></input></td></tr></table>

<h2>2. Investigators</h2>
<p>Applications from investigators based overseas will only be considered if the project is done in collaboration with investigators based in institutions in Sri Lanka who take equal responsibility for the conduct of the study and who will appear as co-authors in any publication arising out of the study.  </p>


<table border="1">
<tr>
<td>Name and designation of Investigator </td>
<td>Role </td>
</tr>
<tr>
<td><input type="text" name="inves1"></input></td>
<td>Principal investigator</td>
</tr>
<tr>
<td><input type="text" name="inves2"></input></td>
<td><input type="text" name="role2"></input></td>
</tr>

<tr>
<td><input type="text" name="inves3"></input></td>
<td><input type="text" name="role3"></input></td>
</tr>


<tr>
<td><input type="text" name="inves4"></input></td>
<td><input type="text" name="role4"></input></td>
</tr>

<tr>
<td><input type="text" name="inves5" width=""></input></td>
<td><input type="text" name="role5" width=""></input></td>
</tr>

<tr>
<td><input type="text" name="inves6" width=""></input></td>
<td><input type="text" name="role6" width=""></input></td>
</tr>

</table>

<p>Please note that the curriculum vitae of all investigators should be attached to the application.</p>

<h2>3. Contact details of the principal investigator.</h2>

<table border="1">
<tr>
<td>Address : </td>
<td><input type="text" name="prinAddress"></td>
</tr>
<tr>
<td>Telephone numbers :</td>
<td><input type="text" name="prinTelephone"></td>
</tr>
<tr>
<td>Fax number :</td>
<td><input type="text" name="prinFax"></td>
</tr>

<tr>
<td>E mail address :</td>
<td><input type="text" name="prinEmail"></td>
</tr>

</table>

<h2>4. Funding.</h2>

<table border="1">
<tr>
<td>Name and address of the funding source(s)</td>
<td>Amount</td>
</tr>
<tr>
<td><input type="text" name="funder"></td>
<td><input type="text" name="amount"></td>
</tr>
</table>

<h2>5. Proposed starting anf ending dates.* &#8225;</h2>

<table border="0">
<tr>
<td>Start date</td>
<td><table border="1"><tr><td><input type="text" name="startDate"></td></tr></table></td>
<td></td>
<td>End date </td>
<td><table border="1"><tr><td><input type="text" name="endDate" width=""></td></tr></table></td>
</tr>
</table>
<p>* From initial recruitment of participants until completion of all data collection.<br/>
&#8225; Retrospective approval will <u>not</u> be given for projects already started or completed. </p>

<h2>6. Has ethics approval for this study been requested from Colombo/ERC or another similar committee?</h2>

<table border="0">
<tr>
<td>Yes </td>
<td><input type="radio" name="6yn" value="yes"></td>
<td>&nbsp;</td>
<td>No </td>
<td><input type="radio" name="6yn" value="no"></td>
</tr>
</table>

<p>If yes, give details (names of committees and outcome of review).</p>
<table border="1"><tr><td><input type="text" name="committee" width=""></input></td></tr></table>

<p>Please note that for studies sponsored by foreign funding agencies or sponsors ethics review and approval is required from the country of the funding agency or the sponsor. </p>

<h2>7. Scientific review</h2>
<p>Has this research proposal been subjected to scientific review by any other committee?</p>
<table border="0">
<tr>
<td>Yes </td>
<td><input type="radio" name="7yn" value="yes"></td>
<td>&nbsp;</td>
<td>No </td>
<td><input type="radio" name="7yn" value="no"></td>
</tr>
</table>

<p>If yes, give details (names of committees and outcome of review)<br/>
What is the name of the committee? </p>
<table border="1"><tr><td><input type="text" name="review" width=""></input></td></tr></table>


<h2>8. Clinical trials</h2>

<table border="0">
<tr>
<td>8.1</td>
<td colspan="2">What phase clinical trial is being conducted?</td>
</tr>

<tr>
<td>&nbsp;</td>
<td>Phase I</td>
<td><input type="radio" name="phase" value="1"></td>
</tr>

<tr>
<td>&nbsp;</td>
<td>Phase II</td>
<td><input type="radio" name="phase" value="2"></td>
</tr>

<tr>
<td>&nbsp;</td>
<td>Phase III</td>
<td><input type="radio" name="phase" value="3"></td>
</tr>

<tr>
<td>&nbsp;</td>
<td>Phase IV (post marketing)</td>
<td><input type="radio" name="phase" value="4"></td>
</tr>

<tr>
<td>&nbsp;</td>
<td>Other</td>
<td><input type="radio" name="phase" value="other"></td>
</tr>

<tr>
<td>&nbsp;</td>
<td>If OTHER specify :</td>
<td></td>
</tr>

<tr>
<td>&nbsp;</td>
<td colspan="2"><table border="1"><tr><td><input type="text" name="committee" width=""></input></td></tr></table></td>
</tr>

</table>
<p><br/></p>

<table border="0">
<tr>
<td>8.2</td>
<td colspan="2">Is it a multi centre trial?</td>
</tr>


<tr>
<td></td>
<td>Yes &nbsp; &nbsp;<input type="radio" name="8.2" value="yes"></td>


<td>No &nbsp; &nbsp;<input type="radio" name="8.2" value="no"></td>

</tr>
<tr><td></td><td colspan="4">If yes, list the other trial sites </td></tr>

<tr><td></td><td colspan="4"><table border="1"><tr><td><input type="text" name="multicenter" width=""></input></td></tr></table></td></tr>

<tr><td></td><td colspan="4">Please attach ethics approval from the sponsoring country or country of the overseas principal investigator (if any)</td></tr>

</table>
<p><br/></p>

<table border="0">
<tr>
<td>8.3</td>
<td colspan="4">Is the clinical trial registered with the clinical trial registry?</td>
</tr>
<tr>
<td></td>
<td>Yes &nbsp; &nbsp;<input type="radio" name="8.3" value="yes"></td>


<td>No &nbsp; &nbsp;<input type="radio" name="8.3" value="no"></td>

</tr>


<tr><td></td><td colspan="4">If yes, give details (name of the register and the registration number) </td></tr>

<tr><td></td><td colspan="4"><table border="1"><tr><td><input type="text" name="tregistry" width=""></input></td></tr></table></td></tr>
</table>

<p><br/></p>

<table border="0">
<tr>
<td>8.4</td>
<td colspan="4">Data safety monitoring board (only if available)</td>
</tr>
<tr><td></td>
<td>
<table border="1">
<tr>
<td>Name and designation of members</td>
<td>Role</td>
</tr>
<tr>
<td><input type="text" name="smember1" width=""></input></td>
<td><input type="text" name="srole1" width=""></input></td>
</tr>
<tr>
<td><input type="text" name="smember2" width=""></input></td>
<td><input type="text" name="srole2" width=""></input></td>
</tr>
<tr>
<td><input type="text" name="smember3" width=""></input></td>
<td><input type="text" name="srole3" width=""></input></td>
</tr>
</table>

</td>
</tr>
<tr><td></td><td>Please attach the curriculum vitae of all members of the DSMB.</td></tr>

</table>
<p><br/></p>


<table border="0">
<tr>
<td>8.5</td>
<td colspan="4">Details of Indemnity and Insurance coverage for participants, investigators and ethics committee </td>
</tr>
<tr><td></td>
<td>
<table border="1">
<tr>
<td><input type="text" name="insurance" width=""></input></td>
</tr>
</table>

</td>
</tr>

</table>
<p><br/></p>

<h2>9. Conflict of interest</h2>

<table border="0">
<tr>
<td><h2>9.1</h2></td>
<td colspan="4"><h2>Do you believe this project has a Conflict of Interest</h2></td>
</tr>
<tr><td></td><td>Commercially</td></tr>
<tr><td></td>
<td>
<table border="1">
<tr>
<td><input type="text" name="commercially"></input></td>
</tr>
</table>
</tr>
<tr><td></td><td>Financially</td></tr>
<tr><td></td>
<td>
<table border="1">
<tr>
<td><input type="text" name="financially"></input></td>
</tr>
</table>
</tr>

<tr><td></td><td>Intellectually</td></tr>
<tr><td></td>
<td>
<table border="1">
<tr>
<td><input type="text" name="intellectually"></input></td>
</tr>
</table>
</tr>

<tr><td></td><td>Other (explain)</td></tr>
<tr><td></td>
<td>
<table border="1">
<tr>
<td><input type="text" name="otherconflicts"></input></td>
</tr>
</table>
</tr>
<tr><td>&nbsp;</td></tr>
</table>
<p><br/></p>


<table border="0">
<tr>
<td><h2>9.2</h2></td>
<td colspan="5"><h2>Does any member of the research team have any affliation with the provider(s) of </h2></td>
</tr>
<tr><td></td>
<td colspan="5"><h2> funding/ support, or a financial interest in the outcome of the research? </h2></td>
</tr>

<tr>
<td></td>
<td>Yes &nbsp; &nbsp;<input type="radio" name="9.2" value="yes"></td>


<td>No &nbsp; &nbsp;<input type="radio" name="9.2" value="no"></td>

</tr>




</table>

<table border="0">
<tr><td>&nbsp;</td>
<td><h2>If yes, please explain :</h2></td>
</tr>
<tr><td rowspan="1">&nbsp;</td>
<td><table border="1"><tr><td><input type="text" name="affliation" width=""></input></td></tr></table></td>
</tr>


</table>
<p><br/></p>

<table border="0">
<tr>
<td><h2>9.3</h2></td>
<td colspan="5"><h2>If there is a duality of interest identified above describe the interest and state whether it </h2></td>
</tr>
<tr><td></td>
<td colspan="5"><h2> constitutes a potential conflict of interest. </h2></td>
</tr>

<tr>
<td>&nbsp;</td>

<td width=""><table border="1"><tr><td><input type="text" name="duality" width=""></input></td></tr></table></td>


</tr>
</table>



</form>


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